Leveraging predictive analytics to estimate clinical trial success
Estimation of the success likelihood of a clinical trial plays a vital role in determining the time and investment it takes to bring efficacious drug treatment to patients to cure and manage disease.
In an interview with CIO Applications, a Silicon Valley-based tech magazine, Blanca Baez, SVP, Global Head of Pharma & Biotech, and Armin Schneider, SVP of Scientific & Medical Affairs of Molecular Health, share their insights on how the company helps in making unbiased evidence-based clinical development and portfolio decisions with its technology platform branded MH Predict, by converting clinical and molecular data and medical knowledge into actionable information. Read more at: https://www.molecularhealth.com/wp-content/uploads/2020/05/MH_Predict_Interview_CIO_Applications_6-2020.pdf
at Molecular Health we share the global concern over the coronavirus pandemic. We want to assure you that we will maintain uninterrupted operation during these challenging times.
Our principal investor is Dievini, the investment company of Dietmap Hopp, focusing on innovative biotechnological products and technologies. Also in Dievini’s investment portfolio is the Tübingen-based company CureVac AG, currently in the news as they ramp up their efforts to develop an mRNA-based coronavirus vaccine.
Molecular Health’s software identifies the best drugs for individual cancer patients, and our customers – hospitals, laboratories, and patients – depend on us to continue to provide high-quality interpretation of tumours, because, especially now, all patients are entitled to the best healthcare possible.
Our software also enables pharmaceutical companies to improve their research and design more effective clinical trials.
In these times of massive transformation, we at Molecular Health have adapted our processes to protect our staff, our partners, and especially those in risk groups:
We are keeping our team safe: all our employees are working from home office.
We strongly support social distancing: all business meetings with customers and partners are now held virtually. Reach out to your contact person at Molecular Health if you have any questions about an upcoming appointment.
We are prepared: if any of our employees should become ill, we will do whatever it takes to remain productive and deliver our services seamlessly.
Thank you for your continued partnership, and please don’t hesitate to contact us if you have any questions or concerns.
Molecular Health starts market entry and product distribution in Eastern Europe
As it gains a foothold in European markets, Molecular Health (MH) has started distributing the latest development of its flagship product, Molecular Health Guide (MH Guide), in the Ukraine, Moldova and Romania. This medical application supports oncologists on delivering the right drug to the right patient at the right time – the very essence of personalized medicine.
Molecular Health, pioneer in data- and analytics-driven precision medicine, expands its efforts toestablish collaborations in Eastern European countries. In cooperation with its partner and distributor, Chisinau-based Oncogene SRL (www.oncogene.eu), Molecular Health starts to bring its technology (Dataome) and products also to hospitals in the Ukraine, Moldova and Romania.
First stop of MH’s roadshow was Kyiv. In front of 25 oncologists MH experts and OncoGene delegates presented MH Guide, a treatment decision-support tool which is registered as in-vitro diagnostic medical device (IVD) in Europe and is CE-compliant with European regulations. MH Guide includes all steps of the clinical genomics workflow in oncology, from raw sequencing data to generating an interactive, editable medical report. It is the first product of its kind in Germany to be reimbursed by public health insurances.
“Strategic partnerships and collaborations are essential for us to grow, as our regional partners enable us to efficiently bring our products to market,” says Stephan Hettich, Head of Business Development & Sales at Molecular Health, speaking of MH Guide.
Next stop was Chisinau, Moldova, before a third opportunity will be taken in March 2020 in Bucharest where MH and Oncogene will exhibit and sponsor the 1st International Congress for Gynecologic Oncology (https://www.icgo2020.eu/).
In future, precise and individual approaches in oncological therapy will play an even more important role in diagnosing and treating patients. As tumors become increasingly better genetically characterized and understood, patients very likely will benefit from such highly targeted approaches prior to treatment.
Molecular Health holds industry symposium at DGP Annual Meeting in Frankfurt
Molecular Health is sponsor and exhibitor at the 103rd Annual Meeting of the German Society of Pathology in Frankfurt.
It holds a lunch symposium on „Scaling the analysis and interpretation of NGS data with the medical device MH Guide in a clinical setting“ (Saturday, June 15, 12:15-1:45 pm). Prof. M. Kanai (Kyoto University Hospital) and Prof. M. Hummel (Charité Institute of Pathology) share their experiences with MH Guide in daily clinical routine.
MH Guide for labs: Augment your annotations quickly
Benefit from our software-aided interpretations for personalized cancer treatment
• Latest and comprehensive clinical evidence gathered from top publications/databases • Oncologist/pathologist reviewed annotations that include treatment options • Seamless integration into existing lab workflow • Intuitive UI/UX • Cloud-based portal for rapid and secure processing
Clinical trials can fail to detect rare adverse events (AEs). We assessed the ability of pharmacological target adverse‐event (TAE) profiles to predict AEs on US Food and Drug Administration (FDA) drug labels at least 4 years after approval. TAE profiles were generated by aggregating AEs from the FDA adverse event reporting system (FAERS) reports and the FDA drug labels for drugs that hit a common target. A genetic algorithm (GA) was used to choose the adverse event (AE) case count (N), disproportionality score in FAERS (proportional reporting ratio (PRR)), and percent of comparator drug labels with an AE to maximize F‐measure. With FAERS data alone, precision, recall, and specificity were 0.57, 0.78, and 0.61, respectively. After including FDA drug label data, precision, recall, and specificity improved to 0.67, 0.81, and 0.71, respectively. Eighteen of 23 (78%) post-market label changes were identified correctly. TAE analysis shows promise as a method to predict AEs at the time of drug approval.
Molecular Health launches MH Mendel for the genetic diagnosis of hereditary diseases
• MH Mendel combines the most relevant information for the diagnosis of hereditary diseases • MH Mendel helps patients and supports physicians through most modern and comprehensive precision medicine technologies and expertise • MH Mendel becomes an integral part of IVD registered Molecular Health Guide® 3.0
Heidelberg, Germany and Boston, USA – June 11, 2018 – Molecular Health (MH), a leading biomedical company that is transforming molecular data into clinically actionable information for efficient and safer cancer treatment options based on its proprietary Dataome® technology platform, has introduced Molecular Health Guide® Mendel (MH Mendel) as part of the established Molecular Health Guide® (MH Guide), a comprehensive software solution for precision medicine. MH Mendel, an integral part of the MH Guide 3.0, a registered IVD product, supports human geneticists in creating a diagnostic report based on their own variant classifications. MH Mendel combines the information that is most relevant for the diagnosis of hereditary diseases. Data from a variety of sources are provided to help human geneticists to assess and classify variants detected in their patients. MH Mendel includes population frequencies, reported clinical significance, and functional impact predictions for a plethora of variants. For analysis of germline variants associated with hereditary diseases, MH Mendel supports human geneticists in managing their own variant classifications and interpretations as well as in creating diagnostic reports. ”Genetic tests can reveal a predisposition to rare hereditary diseases. Today some hereditary diseases can be managed. Early detection and precise understanding is important to initiate treatment and to prevent avoidable irreparable defects. Results of genetic tests analyzed and evaluated by MH Mendel can reveal ae predisposition to diseases and help physicians to find the exact molecular cause and to create a personalized diagnostic report for each patient “, says Dr. Stephan Brock, CTO of Molecular Health. “We are glad that with MH Mendel we can now help patients and support physicians with our advanced and highly curated and integrated precision medicine technologies and expertise.”
Molecular Health receives grant from Bill & Melinda Gates Foundation
Molecular Health to pursue drug repurposing in tuberculosis treatment and perinatal complications
Molecular Health receives grant from Bill & Melinda Gates Foundation
Heidelberg, Germany/Boston, MA, May 16, 2018. Molecular Health announces it was awarded a grant from the Bill & Melinda Gates Foundation. Through the program enabled by the grant, Molecular Health (MH) will leverage computational biomedicine technology and domain expertise captured in MH core assets, Dataome® knowledgebase and MH Effect™ software, to help find shorter, more effective and better-tolerated treatment regimens for TB, and to explore ways to address perinatal complications in developing countries. Dataome® is MH’s biomedicine knowledgebase with comprehensive, current and curated clinico-molecular data and information on targets, molecules, diseases, variants, pathways, drugs and outcomes and will be utilized to identify treatment improvement opportunities in these two areas of unmet need, deriving novel insights on drug outcomes from other areas, such as immuno-oncology. MH Effect™ will allow MH experts to tap onto millions of patient records on drug outcomes to efficiently draw and test treatment hypotheses. Blanca Baez, Global Head of Pharma & Biotech at Molecular Health, expressed: “Our value proposition to drug discovery and drug development is to employ highly specialized in silico research and machine learning techniques to speedily generate, prove and disprove hypotheses for novel, repurposed or combined drug treatments to improve efficacy and safety in specific patient profiles. We do this through clinico-molecular analytics on drug target, mode of action and disease pathways. This grant allows us to continue delivering on this promise.”
SAP is expanding the COPE® program and now also covers the cost of tumor analysis for employees affected by cancer in Australia
Heidelberg, Walldorf, 6 April 2018. From 26 March 2018, SAP will provide access to the “Corporate Oncology Program for Employees” (COPE®), developed by Molecular Health and offered by the Institute of Immunology and Genetics (IIG), also in Australia: If cancer is diagnosed in a SAP employee, the COPE program enables the affected person to have a molecular genetic analysis of the tumor genome prepared in order to find indications for promising therapies.
Approximately 45% of men and 35% of women receive a cancer diagnosis during their lifetimes. Thanks to new technologies for molecular genetic analysis and clinical interpretation, however, cancer patients can now be treated more effectively than ever before. COPE is a milestone in advancing precision medicine. It illustrates SAP’s innovation mindset and caring culture, and the role that SAP HANA® can play in improving decision-making for patient treatment. In the spirit of SAP’s purpose to improve people’s lives, we are dedicated to investing in the health and wellbeing of our employees and to providing innovative benefit options that support colleagues through challenging times.
With COPE, SAP offers eligible employees free and confidential access to precision medicine through an in-depth molecular-medical analysis aimed at helping doctors make better-informed treatment decisions. “Although COPE is not an actual therapy, the program provides treating doctors with information to make better-informed treatment decisions. A doctor treating oncologist receives this recommendation, which incorporates the patient’s genetic profile at the exact moment a decision has to be made. Therefore, treating oncologists can rely, that every recommendation is based on the latest, state-of-the-art science and technology. We believe that the program offers considerable added value for our affected colleagues”, says Dr. Natalie Lotzmann, Global Vice President HR, Head of Global Health Management, SAP. “Employees are the biggest asset of a company. We are delighted that SAP now also in Australia will help their employees affected by cancer through our COPE program”, says Friedrich von Bohlen, CEO of Molecular Health.
Within the context of COPE, Molecular Health Guide™ (MH Guide) is being used: The software processes the genetic sequencing data in a very short time and analyses changes in the tumour genome of the patient. MH Guide matches this individual genetic information with biomedical knowledge currently available worldwide. On the basis of the most recent knowledge, this enables the treating doctors to identify a therapy with the highest potential for the tumour profile and to reduce potential side effects as much as possible. MH Guide thus supports the doctor in the efficient preparation of a therapy recommendation tailored to the individual patient, but the therapy decision is still the responsibility of the treating doctor. Confidentiality is a natural component of this process. The patient remains anonymous. Patient-related information remains confidential and will not be disclosed to third parties or the employer. COPE is offered by several global companies to provide employees free access to a molecular tumour analysis.
Case reports suggest an association between second-generation antipsychotics (SGAs) and serotonin syndrome (SS). The US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) was analyzed to generate hypotheses about how SGAs may interact with pharmacological targets associated with SS. FAERS was integrated with additional sources to link information about adverse events with drugs and targets. Using Proportional Reporting Ratios, we identified signals that were further investigated with the literature to evaluate mechanistic hypotheses formed from the integrated FAERS data. Analysis revealed common pharmacological targets perturbed in both SGA and SS cases, indicating that SGAs may induce SS. The literature also supported 5-HT2A antagonism and 5-HT1A agonism as common mechanisms that may explain the SGA-SS association. Additionally, integrated FAERS data mining and case studies suggest that interactions between SGAs and other serotonergic agents may increase the risk for SS. Computational analysis can provide additional insights into the mechanisms underlying the relationship between SGAs and SS.